The opinion of the court was delivered by: Chesler, U.S.D.J.
This matter comes before the Court on three motions: 1) the motion for partial summary judgment regarding utility and enablement by Plaintiff Ortho-McNeil-Janssen Pharmacueticals, Inc. ("Ortho"); 2) the motion for partial summary judgment of invalidity for double patenting by Defendant Watson Laboratories, Inc. ("Watson"); and 3) the motion for partial summary judgment of invalidity for double patenting by Defendant Lupin Pharmaceuticals, Inc. ("Lupin.") For the reasons stated below, Plaintiff's motion will be granted and Defendants' two motions will be denied.
This is a patent infringement case brought under the Hatch-Waxman Act. On April 10, 2001, the United States Patent and Trademark Office ("PTO") issued U.S. Patent No. 6,214,815 (the "'815 patent"). Ortho owns the '815 patent. The claims of the '815 patent cover the combination oral contraceptive that Ortho markets under the name "Ortho Tri-Cyclen Lo."
In July of 2003, Watson filed an Abbreviated New Drug Application ("ANDA"), No. 90-479, with the United States Food and Drug Administration, seeking approval to market a generic version of Ortho Tri-Cyclen Lo prior to the expiration of the '815 patent. On September 4, 2008, Watson notified Ortho of its certification that the '815 patent is invalid due to anticipation, obviousness, and other grounds. On October 16, 2008, Ortho initiated the instant action by filing a Complaint for infringement of the '815 patent. Lupin has filed a similar ANDA, and Ortho filed a separate action against Lupin, which was consolidated into this action.
The present motions concern claims 1 and 4 of the '815 patent. Among its affirmative defenses to Ortho's claims of patent infringement, Watson contends that claims 1 and 4 are invalid on the following grounds: 1) failure to meet the statutory utility requirement; 2) failure to meet the statutory enablement requirement; and 3) non-statutory double patenting, in view of U.S. Patent No. 4,616,006 (the "'006 patent"). Ortho has moved for partial summary judgment as to Watson's affirmative defenses of invalidity based on the utility and enablement requirements, and Watson has moved for partial summary judgment as to its affirmative defense of invalidity based on non-statutory double patenting. Lupin has moved for partial summary judgment as to the double patenting issue, relying on Watson's briefing.
I. Relevant legal standard
A. Motions for summary judgment Summary judgment is appropriate under FED. R. CIV. P. 56(c) when the moving party demonstrates that there is no genuine issue of material fact and the evidence establishes the moving party's entitlement to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986). A factual dispute is genuine if a reasonable jury could return a verdict for the non-movant, and it is material if, under the substantive law, it would affect the outcome of the suit. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). "In considering a motion for summary judgment, a district court may not make credibility determinations or engage in any weighing of the evidence; instead, the non-moving party's evidence 'is to be believed and all justifiable inferences are to be drawn in his favor.'" Marino v. Indus. Crating Co., 358 F.3d 241, 247 (3d Cir. 2004) (quoting Anderson, 477 U.S. at 255).
"When the moving party has the burden of proof at trial, that party must show affirmatively the absence of a genuine issue of material fact: it must show that, on all the essential elements of its case on which it bears the burden of proof at trial, no reasonable jury could find for the non-moving party." In re Bressman, 327 F.3d 229, 238 (3d Cir. 2003) (quoting United States v. Four Parcels of Real Property, 941 F.2d 1428, 1438 (11th Cir. 1991)). "[W]ith respect to an issue on which the nonmoving party bears the burden of proof . . . the burden on the moving party may be discharged by 'showing' -- that is, pointing out to the district court -- that there is an absence of evidence to support the nonmoving party's case." Celotex, 477 U.S. at 325.
Once the moving party has satisfied its initial burden, the party opposing the motion must establish that a genuine issue as to a material fact exists. Jersey Cent. Power & Light Co. v. Lacey Township, 772 F.2d 1103, 1109 (3d Cir. 1985). The party opposing the motion for summary judgment cannot rest on mere allegations and instead must present actual evidence that creates a genuine issue as to a material fact for trial. Anderson, 477 U.S. at 248; Siegel Transfer, Inc. v. Carrier Express, Inc., 54 F.3d 1125, 1130-31 (3d Cir. 1995). "[U]nsupported allegations. . . and pleadings are insufficient to repel summary judgment." Schoch v. First Fid. Bancorporation, 912 F.2d 654, 657 (3d Cir. 1990); see also FED. R. CIV. P. 56(e) (requiring nonmoving party to "set out specific facts showing a genuine issue for trial"). "A nonmoving party has created a genuine issue of material fact if it has provided sufficient evidence to allow a jury to find in its favor at trial." Gleason v. Norwest Mortg., Inc., 243 F.3d 130, 138 (3d Cir. 2001).
If the nonmoving party has failed "to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial, . . . there can be 'no genuine issue of material fact,' since a complete failure of proof concerning an essential element of the nonmoving party's case necessarily renders all other facts ...